Compact Urinary Catheters and Methods for Making the Same

ABSTRACT

A compact catheter assembly and methods of making such a catheter are disclosed. The catheter assembly incudes a receiver and a catheter sub-assembly. The catheter sub-assembly includes a gripping member and a catheter tube carried by the gripping member.

FIELD OF THE DISCLOSURE

The present disclosure is directed to catheters for use in the medicalfield. More particularly, the present disclosure is directed to urinarycatheters for use in the management of urinary incontinence. Even moreparticularly, the present disclosure is directed to compact intermittenturinary catheters.

BACKGROUND

Catheters are used to treat many different types of medical conditionsand typically include an elongated catheter tube that is inserted intoand through a passageway or lumen of the body. Urinary catheters and, inparticular, intermittent urinary catheters are commonly used byindividuals who suffer from certain abnormalities of the urinary system,such as urinary incontinence. With the advent of intermittent urinarycatheters, individuals with problems associated with the urinary systemcan conveniently self-catheterize to drain the individual's bladder.Individuals who suffer from urinary incontinence will self-catheterizeseveral times a day.

Self-catheterization involves removing the catheter assembly from itspackage and inserting and advancing the catheter tube through theurethra. Users of intermittent catheters are often required toself-catherize outside the privacy of the home, such as in publicrestrooms. Thus, for these and other reasons, it is desirable thatintermittent catheters are provided in discrete packaging that is easyto open, compact and portable, and easy to dispose.

SUMMARY

In one aspect, the present disclosure is directed to a catheterassembly. The catheter assembly includes a catheter sub-assembly thathas a gripping member and a catheter tube carried by the grippingmember. The catheter tube defines a flow path and the gripping memberhas a distal end with an aperture in the distal end that communicateswith the flow path of the catheter tube. The catheter assembly furtherincludes a receiver for receiving at least a portion of the cathetertube. The receiver includes an elongated body and an outer surface andan inner surface defining an interior chamber.

In another aspect, the present disclosure is directed to a catheterassembly including a receiver and a gripping member where the receiverand gripping member when assembled define an outer, elongated housing.The housing has first and second opposed ends and a longitudinal centralaxis between the ends. The housing has a non-circular profile about thecentral axis. The catheter tube is carried by the gripping member.

In a further aspect, the present disclosure is directed to a cathetersub-assembly. The catheter sub-assembly includes a gripping member and acatheter tube carried by and attached to the gripping member. Thecatheter assembly has a central longitudinal axis. The catheter tube hasa proximal end and distal end defining a flow path between the ends, andthe gripping member includes an outer gripping surface and an aperturein the outer gripping surface in flow communication with the flow pathof the catheter tube.

In a more specific aspect, the catheter assemblies and sub-assembliesdisclosed herein may include a hydration element disposed within theinterior chamber of the receiver. In a further more specific aspect, thehydration chamber may be a sachet that is liquid impermeable and vaporpermeable.

In yet another more specific aspect, the catheter assemblies andsub-assemblies disclosed herein may include a security tab placed overthe aperture in the distal end of the gripping member.

In a further more specific aspect, the security tab may also be part ofa larger tamper-evidencing band that seals the junction of the receiverand gripping member.

In yet another specific aspect, the catheter and catheter sub-assembliesdisclosed herein may include a full-length or partial sleeve disposedover the catheter tube of the catheter sub-assembly.

In yet another specific aspect, the catheter and catheter sub-assembliesof the present disclosure may include a notch at the proximal end of thegripping member for receiving and maintaining the catheter tube in anorientation that is angled from the central longitudinal axis.

In a further aspect, the present disclosure is directed to a method ofmaking a catheter assembly that includes a receiver and a cathetersub-assembly. The receiver has non-circular outer housing portiondefining an interior chamber and including a receiver port, while thecatheter sub-assembly includes a gripping member having a non-circularouter housing and a catheter tube attached thereto. The method includesforming at least a portion of the receiver, forming the gripping member,attaching one end of the catheter tube to the gripping member, andintroducing a free end of the catheter into the receiver. A securityband may be applied to the juncture of the receiver and the cathetersub-assembly.

In a more specific aspect, the catheter assembly may be formed byforming a first portion of the receiver and separately forming a secondportion of the receiver housing.

In a more specific aspect of the method of making the catheter assembly,the method may include introducing a hydration element into thereceiver. The receiver may be attached to a wall of the interior chamberor simply placed within the interior chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the catheter assembly housing of thepresent disclosure;

FIG. 2 is an exploded view of the catheter assembly of the presentdisclosure showing the receiver and catheter sub-assembly.

FIG. 3 is a distal end view of the catheter assembly housing with theprotective tab disposed over the aperture;

FIG. 4 is a distal end view of the catheter assembly housing of thepresent disclosure with the protective tab removed;

FIG. 5A is a cross-sectional side view of the catheter assembly of thepresent disclosure in its assembled state;

FIG. 5B is a cross-sectional side view of the catheter assembly of thepresent disclosure showing the catheter sub-assembly being removed fromthe receiver;

FIG. 5C is a cross-sectional side view showing the different componentsthat may make up one embodiment of the catheter assembly of the presentdisclosure;

FIG. 6 is a cross-sectional side view of the catheter sub-assembly ofFIG. 5A with a protective sleeve over the catheter tube;

FIG. 7 is a cross-sectional side view of the catheter sub-assembly ofFIG. 6 showing the sleeve being retracted and the catheter tube exposed;

FIG. 8 is a side view of a catheter sub-assembly without a protectivesleeve;

FIG. 9 is a view of the catheter sub-assembly of the present disclosurewith a full-length sleeve disposed over the catheter tube;

FIG. 10 is a side view of the catheter sub-assembly of the presentdisclosure with a partial length sleeve disposed over the catheter tube;

FIG. 11 is a side view of the catheter sub-assembly of the presentdisclosure showing a full-length sleeve disposed over the catheter tubeand a introducer tip located at the distal end tip of the catheter tube;

FIG. 12 is a perspective view of the catheter sub-assembly withdrawnfrom the receiver;

FIG. 13 is a side view showing the catheter tube of the catheterassembly in an upstanding orientation;

FIG. 14 is cross-sectional side view of the catheter assembly of FIG. 13with the catheter tube in varying angled orientations;

FIG. 15 illustrates the opening of the catheter assembly of the presentdisclosure;

FIG. 16 is a partial end view in perspective with the protective sealingtab disposed over the aperture in the distal end;

FIG. 17 shows the catheter sub-assembly of the present disclosuregrasped by a user;

FIG. 18 illustrates the removal of the protective sealing tab from thecatheter sub-assembly of the present disclosure;

FIG. 19 shows another embodiment of a sealing tab/tamper evidencing bandof the present disclosure;

FIG. 20 shows a step in the sequence of opening the catheter assembly byremoving the tamper evidencing band;

FIG. 21 shows a further step of the opening sequence showing the removalof the tamper evidencing tab;

FIG. 22 is a partial perspective view of the receiver distal end with aportion cut away to show the hydration element disposed therein;

FIG. 23 is a cross-sectional partial view of the distal end portion ofthe receiver with part of a catheter tube and part of the hydrationelement disposed therein;

FIG. 24 is another cross-sectional side view of the end of the distalend of the receiver showing the catheter tube and the hydration elementsecured at the distal end of the receiver;

FIG. 25 is a partial perspective view of the distal end with a portioncut away to show the hydration element being disposed therein;

FIG. 26 is a cross-sectional side view of the distal end portion of thereceiver with the catheter tube and the hydration element disposedtherein;

FIG. 27 shows is a cross-sectional view of the distal end portion of thereceiver with the hydration element secured at the distal end of thereceiver;

FIG. 28 is a partial perspective view of a container being attached tothe distal end of the catheter assembly of the present disclosure;

FIG. 29 is a perspective view of the container attached to the distalend of the catheter sub-assembly;

FIG. 30 is a perspective view of a one-piece receiver and a hydrationelement;

FIG. 31 is a perspective view showing the receiver of FIG. 30 with thehydration element being introduced into the receiver;

FIG. 32 is a perspective view of the receiver of FIG. 30 with thehydration element fully inserted into the receiver;

FIG. 33 is a perspective view of a method of assembling a receiverformed from two parts;

FIG. 34 is a perspective view of the receiver of FIG. 33 in itsassembled state;

FIG. 35 is a perspective view of an alternative embodiment of receiverformed from two parts being assembled;

FIG. 36 is a side view of the receiver of FIG. 35;

FIG. 37 is a perspective view of one embodiment of the cathetersub-assembly with the gripper and catheter tube being assembled;

FIG. 38 is a cross-sectional side view of the gripping member of FIG. 37with the catheter tube seated therein;

FIG. 39 is a perspective view showing one method by which catheter tubemay be introduced into the gripping member;

FIG. 40 is a cross-sectional side view showing the step of introducingthe catheter tube into the gripping member as shown in FIG. 38; and

FIG. 41 is a cross-sectional side view showing the catheter tube fullyseated and installed and assembled with the gripping member.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The embodiments disclosed herein are for the purposes of providing adescription of the present subject matter. The catheter assemblies,catheter sub-assemblies, methods of use and methods of manufacturedisclosed herein may be embodied in various other forms and combinationsnot specifically shown in detail or illustrated in any one figure.Therefore, specific embodiments are not to be interpreted as limitingand the features disclosed and illustrated are not to be interpreted aslimited to any one specific embodiment described or illustrated.

FIG. 1 illustrates a catheter assembly 10 in accordance with the presentdisclosure. Catheter assembly 10 includes receiver 14 and cathetersub-assembly 16 that are provided in an assembled form and define anouter elongated housing 12. Catheter sub-assembly 16, in turn, includesa gripping member 18 and a catheter tube 20 carried by the grippingmember 18, as shown in FIG. 2. When assembled, outer elongated housing12 has a top surface 15 a and bottom surface 15 b and further includesproximal and distal ends 13 a and 13 b, respectively.

The terms “distal” and “proximal” are used throughout this disclosure.When used in the context of the catheter tube that is inserted into thebody of the user, the term “proximal” is used to refer to that end orportion of the catheter tube that during use is closer in proximity tothe user's body and/or initially enters the user's body upon insertion.The term “distal” is used to refer to an end or portion of the cathetertube that is opposite the proximal end or portion and is typicallyfurther away from the user's body. For the sake of consistency, when theterms “distal” and “proximal” are used in the context of a housing ormember that receives or carries the catheter tube such as the receiverand gripping member, which are not intended for introduction into theuser's body, a proximal end or proximal portion is that end or portioncloser to the proximal end of the catheter tube when the catheter tubeis housed or carried by such housing or member, while the distal end orportion is located opposite to such proximal end or portion.

As shown in FIGS. 1 and 2, housing 12 of catheter assembly 10 ispreferably compact and portable, i.e., having a size that can, forexample, be easily carried in a handbag or purse. Catheter assembly 10and, in particular, housing 12 preferably has a longitudinal dimensionsufficient to house a catheter tube 20 intended for use by a user.Female catheter tubes 20 are typically shorter in length than malecatheters and have a length of approximately 100-110 mm. Housing 12 mayhave any shape or exterior profile that allows for easy handling by theuser and is not readily identifiable as a medical product. Thus, in oneembodiment, housing 12 of catheter assembly 10 has a non-circularprofile or shape about the central longitudinal axis 15. Moreparticularly, as shown in FIGS. 1-5, housing 12 of catheter assembly 10has a generally elliptical shape or end profile about central axis 15.Housing 12 of FIGS. 1-5 is referred to as generally elliptical in thesense that it may not be a perfect ellipse but may have a top surface 15a and bottom surface 15 b that are slightly flattened and side surfaces15 c and 15 d that may be slightly less arcuate than a true ellipse oroval. The slightly flattened top and bottom surfaces 15 a and 15 b allowfor a larger gripping area for grasping by a user. Of course, catheterassembly 10 of the present disclosure may be provided in other shapesthat are preferably, but not exclusively non-circular. As further shownin the Figures, housing 12 may have a uniform and substantiallysymmetrical shape about the longitudinal axis 15 and may be free of anysharp corners and edges. Side surfaces 15 c and 15 d of housing 12 maybe curved and of a shorter width than the top and bottom surfaces 15 aand 15 b, thereby providing catheter assembly 10 with a slender profilewhen viewed from the side. Also, when viewed from the side, housing 12of catheter assembly 10 may include a diminishing taper toward housingends 13 a and 13 b, as shown in FIG. 2.

Housing 12 is preferably made of a light-weight, substantially rigidpolymeric material. Preferably, the polymeric material is a relativelyrigid material that protects the contents of the catheter assembly 10.In addition, it is preferable that the polymeric material of housing 12be non-transparent and opaque, such that the contents of housing 12cannot be easily identified. Polymeric materials that are suitable foruse in housing 12 include polycarbonate, Nylon, ABS and polyethylene.The surface of housing 12 should be reliably gripable and not slipperyto the touch. Thus, at least a portion of housing 12 may be textured orroughened to enhance gripping by the user. In addition to being texturedor roughened, at least gripping member 18 may further include grippingelements which may be provided by raised areas on the surface of housing12, such as embossed lettering or the like.

As discussed above, catheter assembly 10 and, in particular, housing 12may include a relatively wider top and bottom surfaces 15 a and 15 b,thereby providing the user with a wider surface area for grasping andtwisting by the user during the opening sequence. As shown in FIGS.5A-C, catheter assembly 10 is preferably made of multiple parts,including at least receiver 14 and catheter sub-assembly 8. Receiver 14is elongated, and as discussed above, includes top and bottom exteriorsurfaces 15 a and 15 b, which together with the side surfaces 15 c, 15 ddefine and interior chamber within receiver 14. As discussed in greaterdetail below, receiver 14 may be of one-piece construction or multi-partconstruction. Receiver 14 includes a closed proximal end 14 a and adistal end 14 b.

In another embodiment, housing 12 may include three molded parts joinedtogether, as shown in FIG. 5C. In the three-part embodiment, as shown inFIG. 5C, housing 12 may include receiver 14, gripping member 18 andthreaded stopper 19. Stopper 19 provides the threaded neck 28 ofreceiver port 26. Threaded stopper 19 may be attached to the distal endof receiver 14 by press-fitting or other means. As shown in FIG. 5C,stopper 19 includes threaded neck 28 and at least a pair ofproximally-extending prongs 19 a/19 b that snugly fit within and matewith the inner surfaces of the interior chamber of receiver 14. Furthermovement of stopper 19 is prevented by the distal edge of receiver 14.The entire catheter assembly 10 may be assembled by fitting the distalend of catheter tube 20 into the channel of gripping member 18. If ahydration element 48 (discussed in greater detail below) is included,hydration element 48 may first be introduced into the interior chamberprior to attachment of stopper 19. Stopper 19 may then be attached toreceiver 14 which also secures the sachet of hydration element 48 withinreceiver 14. Stopper 19 may be secured to receiver 14 by any one ofinterference fit, adhesive bonding, ultrasonic welding or spin welding.Catheter sub-assembly 16 and receiver 14 may then be assembled.

As shown in FIG. 5C, in one embodiment, distal end 14 b includescontacting surface 32, which contacts a corresponding surface ofgripping member 18 when catheter assembly 10 is in its assembled state.Distal end surface 32 may be shaped in a way that is complementary tothe shape of the distal end of gripping member 18. Distal end surface 32includes an opening to allow for insertion of catheter tube 20.

As shown in the FIGS. 2 and 5A-5C, in one embodiment, distal end surface32 includes and/or supports a receiver port 26. Receiver port defines anopening in receiver 14 that allows insertion of catheter tube 20 ofcatheter sub-assembly 16. Receiver port includes a neck 28 whichterminates in an opening in port 26 sufficiently sized to receive acatheter tube 20 and from which catheter tube can be freely withdrawn.Neck 28 may include an engagement surface for cooperative engagementwith a corresponding surface of gripping member 18. Thus, as shown inFIG. 5C, neck 28 may be threaded to allow for threaded engagement anddisengagement with corresponding threads on gripping member 18. Othermeans of securing receiver 14 to gripping member 18 that will be knownto those of skill in the art are also within the scope of thisdisclosure.

As indicated above and with reference to FIGS. 6-7, cathetersub-assembly 16 includes gripping member 18 and catheter tube 20attached to and carried by gripping member 18. Catheter tube 20 includesa proximal end portion 21 and distal end portion. Preferably, cathetertube 20 is carried by and secured to gripping member 18 at the distalend of catheter tube 20. Catheter tube 20 defines a flow path for urinethat is drained from the body of a user. Thus, catheter tube 20 includeseyelet openings 23. Urine enters through the eyelets 23 and travels downthe flow path of catheter tube 20 where it can be drained into a toilet(WC) or an attached receptacle.

Catheter tube 20 may be made of a biocompatible polymeric materialhaving sufficient stiffness that it can be easily inserted into the bodyof the user, yet flexible enough to avoid causing pain or discomfort tothe user and to allow for movement within the urinary canal. Materialsthat are suitable for use as catheter tube 20 include polyvinylpyrrolidone (PVP), polyamide, polyanhydride, polyether, poly(etherimide), poly(ester imide), polyvinyl alcohol, polyvinyl chloride,polycarbonate, poly(ε-caprolactone) with polymethylvinylsiloxane,poly(ethylene-co-(vinylacetate)) with dicumylperoxide, poly(D-lactide),poly(L-lactide), poly(DL-lactide) andpoly(glycolide-co-(ε-caprolactone))-segments, multiblock copolyestersfrom poly(ε-caprolactone) and PEG and chain extender based on cinnamicacid groups, poly(ε-caprolactone) dimethacrylate and n-butyl acrylate,oligo(ε-caprolactone) diols, oligo (p-dioxanone) diols and diisocyanate,linear density polyethylene, linear low density polyethylene, highdensity polyethylene, and polypropylene. Catheter tube 20 may also beentirely made of a hydrophilic material or a material that has been madehydrophilic. Catheter tube may also include a hydrophilic coating on atleast a portion of outer surface thereof, which when contacted by anaqueous, partially aqueous, or non-aqueous liquid enhances the lubricity(and reduces the co-efficient of friction) of catheter tube 20. Cathetertubes that are activated by agents to make the catheter tube 20 morelubricious are known and sold in products under the trademarks VaPro™and VaPro™ Plus, sold and distributed by Hollister Inc. of Libertyville,Ill. Additional details of such hydrophilic catheters and activationthereof are described in U.S. Pat. No. 8,051,981, which is incorporatedherein by reference. Alternatively, catheter tube 20 may be lubricatedby providing a friction-reducing material such as a gel within areservoir of introducer tip 46 (shown in FIG. 11 and further describedbelow), which coats catheter tube 20 as catheter tube passes throughintroducer tip 46. Catheter assemblies that include a gel reservoir in aprotective introducer tip are sold in products under the trademarksAdvance™ and Advance™ Plus, also distributed by Hollister Inc. ofLibertyville, Ill..

As shown in FIGS. 2, 6-7 and 9-11, catheter tube 20 may optionally beprovided with a partial or substantially full-length sleeve 22 over theouter surface of catheter tube 20. Sleeve 22 may be made of a flexible,relatively thin polymeric film material that allows the user to graspcatheter tube 20 through sleeve 22 and thereby avoid direct contact withcatheter tube 20 and the possibility of contamination of catheter tube20. For example, in use, the user grasps and manipulates catheter tube20 through sleeve 22, advancing catheter tube 20 into the urethra whilefolding or bunching sleeve 22 at the distal end portion 21 of cathetertube 20, as seen in FIG. 7. “No-touch” sleeve 22 is preferably made of amaterial that is capable of being folded onto itself or bunched duringinsertion of catheter tube 20. Polymeric film materials suitable for useas sleeve 22 include (but are not limited to) polyethylene, plasticizedPVC, polypropylene, polyurethane or elastomeric gels. With reference toFIG. 11, catheter tube 20 may further include introducer tip 46 placedover the catheter tip at proximal end portion 21 Introducer tip 46 isused to assist in positioning of the proximal end of catheter tube 20during introduction into the urethra of the user, and to protect theproximal end of the catheter tube 20 from contamination by bacteria inthe distal urethra.

Referring to FIGS. 12-14, catheter tube 20 extends from gripping member18 and is generally oriented along and coincident with centrallongitudinal axis 15. However, during introduction (or withdrawal) ofcatheter tube 20, users may wish to adjust the orientation of cathetertube 20 for positioning over a receptacle and/or for physical comfort.Thus, in accordance with the present disclosure, catheter tube 20 may beadjusted and maintained at an angle to central longitudinal axis 15. Inone embodiment shown in FIGS. 13-14, the position of catheter tube 20may be angularly adjusted relative to the central longitudinal axis 15by a desired angle α. Catheter tube 20 may be tilted and bent away fromthe central longitudinal axis 15 at angles up to approximately 90°, ifdesired, but more typically on the order of 45° or less.

In that regard, as further seen in the FIGS. 12-14, gripping member 14may include a notch 44 positioned at or near proximal end surface 34 ofgripping member 14. When catheter tube 20 is adjusted to the desiredangle relative to the central longitudinal axis 15, as described above,notch 44 provides a retainer for maintaining catheter 20 in such angledposition. Notch 44 may be keyhole-shaped and include a narrow channel 44a that opens to a wider window 44 b (as shown in FIG. 12) sized tocomfortably receive catheter tube 20 without squeezing, pinching orkinking of the catheter tube 20. Thus, as shown in FIG. 14, cathetertube 20 may be disposed in a relatively vertical orientation (i.e., bentat an approximately 90° angle) when held within window 44 b or a moreangled orientation (less than approximately 90°) when held withinchannel 44 a.

In addition, to carrying catheter tube 20 and providing a grippingsurface for the user, gripping member 18 also provides a closure forreceiver 14 of housing 12. As discussed above, gripping member 18includes a proximal end or surface 34 that has a profile or shape thatis complementary to the profile or shape of receiver distal end surface32, previously discussed, when receiver 14 and catheter sub-assembly 16are brought together in an assembled state. Thus, as shown in FIG. 2, ifproximal end surface 32 of receiver is concave, distal end of grippingmember 18 will typically be convex. Surfaces 32 and 34 may have othershapes or profiles that are likewise complementary, includingnon-curves, generally flat surface as shown in FIG. 5C. When the endsurfaces 32 and 34 are in contact and receiver 14 and gripping member 18are assembled, separation line 42 may be visible (FIG. 1).

In an embodiment, gripping member 18 also includes aperture 36 in thedistal end 19 b of gripping member 18. Aperture 36 is in flowcommunication with the flow path of catheter tube 20 and provides anoutlet for urine that is drained from the bladder of the user. In oneembodiment shown in FIGS. 5A-5C, aperture 36 communicates with flow pathof catheter tube 20 through, for example, channel 37 located at thedistal end of gripping member 18. Channel 37 may include a surface thatis suited for engagement by an attachment member of a urine collectionreceptacle (discussed in more detail below). Thus, in one embodiment,surface 39 of channel 37 may be threaded. In another embodiment, acorresponding attachment member of the urine collection receptacle mayprovide a surface adapted for friction-securement with aperture 36.

Prior to use, aperture 36 may be sealed from the outside environment toprotect the contents of the catheter assembly 10 from ingress ofairborne bacteria or microorganisms through aperture 36, and also toprevent premature urine flow. Thus, gripping member 18 preferablyincludes a removable tab 38 or other sealing element over aperture 36,shown in FIGS. 15-18. In one embodiment, sealing tab 38 may be a tapehaving an adhesive on at least a portion of the underside that adheresto the outer surface of housing 12. Tab 38 is applied onto top surface15 a and/or bottom surface 15 b and over distal end 19 b of grippingmember 18. Tab 38 may include a wider region 38 a that provides anenlarged grasping surface for the user and that narrows to a narrowerstrip portion 38 b. Tab 38 preferably is made of a foil or other oxygenor moisture barrier material that can be heat sealed and/or otherwiseadhered to the surface of gripping member 18.

Tab 38 may extend into receiver 14 across separation line 42 as shown inFIG. 16. Relative twisting (e.g., 180°) of receiver 14 and grippingmember 18 breaks the tab along separation line 42, as shown in FIG. 15.In that regard, tab 38 may also function as a tamper evidencing band.Gripping member 18 may further include a recess or depression 41 toaccommodate and/or receive a portion of tab 38. Recess 41 may be locatedon top or bottom surfaces 15 a and/or 15 b of gripping member 18, asshown in FIG. 18. Recess 41 may extend across separation line 42 intoreceiver 14, as necessary. Recess 41 provides room for the user to graspan end of tab 38 to begin the unsealing process. In use, sealing tab 38may remain over aperture 36 until catheter tube 20 has been introducedinto the urethra and gripping member 18 is comfortably positioned overthe urine receptacle (e.g., toilet, WC). Where a container or receptacleis attached to gripping member 18, tab 38 must first be removed,container attached and catheter tube 20 then introduced in the urethra.

In another embodiment, tab 38 may be part of a larger and longer tamperband 40, as shown in FIGS. 19-21. Tamper band 40 may be shaped andconfigured to allow for sealing of the catheter assembly alongseparation line 42, while also acting as a sealing member over aperture36. As shown in FIGS. 19-21, tamper band 40 may be wrapped aroundhousing 12 at separation line 42 and include a portion that is generallyperpendicular to the band section about separation line 42 that extendsover gripping member 18 and, more specifically, over aperture 36. FIGS.19-21 show the unwinding sequence of such a tamper band 40, whereby theuser grasps an end of the tamper band and by pulling tamper band 40removes it from separation line 42. Continued pulling of tamper band 40then exposes aperture 36 and makes the catheter assembly ready for use.

As discussed previously, catheters, and specifically catheter tube 20 ofthe type disclosed herein, are preferably made of a hydrophilic materialwith a coating applied to the outer surface thereof where the coating iswetted or activated by a suitable agent to make tube 20 lubricous ormore lubricious and reduce the coefficient of friction to allow for easyadvancement and movement through the urethra. The lubricating agent,preferably water or other aqueous solution, may be directly applied totube 20 from liquid contained within a package or, more preferably, maybe released and come into contact with tube 20 either as liquid or vaporover a period of time.

Thus, in accordance with the present disclosure and as shown in FIGS.5A-5C, the catheter assembly described herein may include a hydrationelement that is used to activate catheter tube 20. Hydration element 48may provide water or the other aqueous solution as a vapor or liquid.Hydration element may be contained within the interior chamber ofreceiver 14.

In one embodiment, hydration element 48 is provided as a sealed sachetor pillow 48 that includes water or other aqueous solution within it.Hydration element 48 is preferably made of a suitable material that isselected to release the hydrating agent through its walls. In addition,the hydration element may include an insert made of a material thatretains water or other aqueous solution. In one embodiment, the insertmay be made of calcium carbonate, while the walls of the hydrationelement containing the insert may be made of a polymeric material thatis vapor permeable but liquid impermeable.

With reference to FIGS. 33-36, hydration element 48 may be freely placedwithin the interior chamber of receiver 14. Alternatively, as shown inFIGS. 23-27, hydration element 48 or a portion thereof may be secured tothe inner wall defining the interior chamber of the receiver 14. In oneembodiment, an elongated hydration element 48 extends along theelongated inner wall of receiver 14 and to the elongated wall along oneor both edges of element 48. Alternatively, an end of hydration element48 may be secured to the inner proximal end wall of the interior chamberof receiver 14. As shown in FIGS. 22-27, hydration element 48 may beattached at one end 48 a to interior end wall of the receiver closeddistal end 14 a. Hydration element 48 may be attached by light spotwelding or adhesive. Alternatively, as seen in FIGS. 22-27, hydrationelement 48 may be provided with a hole or slit 49 located at its end,which is sized to fit over retaining post 50 in receiver 14. Post 50, inturn, may be in the form of one or more upstanding prongs 52, which whenbent or folded downwardly press the end of retaining element 48 andsecure the end of hydration element 48 within receiver 14. Of course,other means of securing hydration element 48 may also be used.

As indicated above and shown in FIGS. 28-29, aperture 36 of grippingmember 18 may serve as an outlet port for urine that has been drainedfrom the patient. Aperture 36 may also provide an attachment point for aurine collection container 60. The urine collection container 60 maylikewise have an end suited for attachment to aperture 36. For example,where gripping member 18 includes aperture 36 and a channel 37 with aninternal threaded surface 39, container 60 may be provided to include acorresponding external thread or attachment member 62, as shown in FIG.30. Attachment of container 60 to aperture 36 may also be accomplishedby other means, such as a friction fit between a corresponding ring orbead on attachment member 62 capable of being press-fit in acorresponding slot of channel 37.

The individual components of receiver 14 and catheter sub-assembly 16and more specifically gripping member 18 may be made of single and/ormulti-piece construction. As discussed above, receiver 14 and grippingmember 18 that define housing 12 are preferably made of rigid polymericmaterial. In one embodiment, receiver 14 and gripping member 18 ofhousing 12 may be molded. In one more particular embodiment, receiver 14may be blow molded, providing a one-piece receiver 14, as shown in FIGS.30-32. Alternatively, receiver 14 may be of two-part construction witheach part being, for example, separately injection molded andsubsequently assembled together. As shown in FIGS. 35-36, receiver 14may be made of two injection molded parts 64 and 66. Receiver parts 64and 66 may then be joined together in a snap-fit arrangement byproviding each of the parts 64 and 66 with corresponding tabs 70 andnotches 72 for interengagement. Parts 64/66 may be secured or furthersecured by adhesive or ultrasonic welding to provide a closed, sterilehousing. The molded parts 64 and 66 may be substantially identicaland/or identically sized or, as shown, in FIGS. 35-36, can be separatelymolded as a base 64′ and lid 66′. Parts 64′ and 66′ may be secured toeach other by tabs and notches as described above, and by adhesive orultrasonic welding.

Similarly, as shown in FIG. 37 gripping member 18 may be made oftwo-piece construction, including two corresponding injection moldedparts 68 and 69 each having comparable and corresponding tabs 70 andnotches 72 for attachment (not shown). As with receiving member 14, thetwo-parts of gripping member 18 may further be secured using adhesive orultrasonic welding.

Catheter tube 20 may be assembled with gripping member 18 in any one ofseveral ways. As shown in FIG. 38, catheter tube 20 may be provided witha hub 76 attached at or near distal end of catheter tube 20. Hub 76 maybe in the form of a cylindrical barrel or other shape. Hub 76 may alsobe the cylindrical portion of a pre-existing and pre-attached cathetertube funnel, as described in International Patent Publication No. WO2012/134804, which is incorporated herein by reference. Where sleeve 22is provided with catheter tube 20, sleeve 22 may be lightly welded orotherwise adhered to hub 76.

Gripping member 18 may be molded or otherwise formed to includecompartments 78 and 80 to receive/accommodate hub 76 and sleeve 22.Compartment 78 may be distally located and sized and adapted forreceiving hub 76. In one embodiment, compartment 78 may be sized toreceive hub 76 in a press-fit or snap-fit relationship. A secondcompartment 80 may be proximally located relative to compartment 78 andmay be sized to accommodate sleeve 22 as sleeve is folded and/or bunchedup during introduction of catheter tube 20. As shown in FIG. 37,compartments 78 and 76 are separated from one another by inwardlyextending wall segments 79, which prevents movement of hub beyondcompartment 76. Where gripping member 18 is made of two-piececonstruction from separately molded parts, each half or molded portionof gripping member 18 will include a half of compartments 76 and 78. Inan alternative embodiment, catheter tube 20 with hub 76 and optionalsleeve 22 may simply be inserted through aperture 36, as shown in FIGS.39-41. Catheter tube 20 with hub 76 may be pressed through aperture 36until hub is seated within a corresponding compartment in aninterference fit-type engagement.

With reference back to FIGS. 30-32, where receiver 14 is made of blowmolded construction, hydration element 48 may also be provided in theshape of a bottle having a widened chamber 88 and container neck 90, asshown in FIG. 32. In such embodiment, hydration element 48 may be rolledor folded and introduced through the receiver port 26, as shown in FIGS.33-34. Once inside the interior chamber of receiver 14, hydrationelement 48 will unroll and expand. Water or other aqueous solution usedfor hydration may then be introduced through the neck portion 88 ofhydration element 48. Neck portion may then be sealed to prevent leakageor escape of liquid from hydration element 48.

It will be understood that the embodiments described above areillustrative of some of the applications of the principles of thepresent subject matter. Numerous modifications may be made by thoseskilled in the art without departing from the spirit and scope of theclaimed subject matter, including those combinations of features thatare individually disclosed or claimed herein. For these reasons, thescope hereof is not limited to the above description but is as set forthin the following claims.

1. A catheter assembly comprising: a) a catheter sub-assembly comprisinga gripping member and a catheter tube carried by said gripping member,said catheter tube defining a flow path, said gripping member having adistal end and an aperture in said distal end; and b) a receiver forreceiving at least a portion of said catheter tube, said receivercomprising an elongated body comprising an outer surface and an innersurface defining an interior chamber.
 2. The catheter assembly of claim1 wherein said receiver comprises an open distal end.
 3. The catheterassembly of claim 1 wherein each of said receiver and said cathetersub-assembly include engagement surfaces for engagement of said grippingmember and said catheter sub-assembly.
 4. The catheter sub-assembly ofclaim 3 wherein said receiver comprises a distally extending neckcomprising said receiver engagement surface.
 5. The catheter assembly ofclaim 3 wherein each of said receiver and catheter sub-assemblyengagement surfaces comprises threaded surfaces.
 6. The catheterassembly of claim 1 wherein said gripping member and said receiver aremade of molded polymeric material.
 7. The catheter assembly of claim 1wherein said gripping member provides a closure for said receivingmember.
 8. The catheter assembly of claim 1 wherein each of saidgripping member and said receiver comprises contacting end surfaces. 9.The catheter assembly of claim 8 wherein said contacting end surfacesinclude complementary profiles.
 10. The catheter assembly of claim 9wherein said contacting end surface of one of said receiver and saidgripping member has a generally concave profile and said end surface ofsaid other of said receiver and said catheter sub-assembly has agenerally convex profile.
 11. The catheter assembly of claim 1 whereinsaid catheter sub-assembly includes a removable seal over said aperture.12. The catheter assembly of claim 1 comprising a tamper band.
 13. Thecatheter assembly of claim 12 wherein said tamper band is disposed atsaid end surfaces of said receiver and catheter sub-assembly whenassembled.
 14. The catheter assembly of claim 13 wherein said tamperband is continuous with said removable aperture seal.
 15. The catheterassembly of claim 8 wherein said contacting end surfaces of saidreceiver and said gripping member when assembled define a separationline sealed by said tamper band.
 16. The catheter assembly of claim 15wherein a portion of said tamper band seals said separation line and aportion of said band seals said aperture.
 17. The catheter assembly ofclaim 1 wherein said catheter sub-assembly further comprises a flexiblesleeve disposed over at a least a portion of said catheter tube.
 18. Thecatheter assembly of claim 1 wherein said catheter sub-assemblycomprises a hub associated with said catheter tube.
 19. The catheterassembly of claim 18 wherein said hub is positioned at said distal endof said catheter tube.
 20. The catheter assembly of claim 19 whereinsaid catheter tube is coaxial with said hub.
 21. The catheter assemblyof claim 18 wherein said gripping member comprises a compartment forreceiving said hub.
 22. The catheter assembly of claim 1 wherein saidgripping member comprises a sleeve-collecting compartment.
 23. Thecatheter assembly of claim 22 wherein said sleeve-collecting compartmentis proximally spaced from said hub-receiving compartment.
 24. Thecatheter assembly of claim 1 wherein said gripping member comprises achannel between a distal end of said catheter tube and said aperture.25. The catheter assembly of claim 24 wherein said channel comprises aninner surface adapted for attachment of a container.
 26. The catheterassembly of claim 25 wherein said channel inner surface is threaded. 27.The catheter assembly of claim 25 further comprising a container. 28.The catheter assembly of claim 1 further comprising a hydration element.29. The catheter of claim 28 wherein said hydration element is containedwithin said interior chamber of said receiver.
 30. The catheter assemblyof claim 28 wherein said hydration element comprises a sachet containinga moisture-donating liquid.
 31. The catheter assembly of claim 30wherein said moisture-donating liquid comprises liquid water.
 32. Thecatheter assembly of claim 28 wherein said hydration element is made ofa material that is liquid impermeable and vapor permeable.
 33. Thecatheter assembly of claim 28 wherein said hydration element is securedwithin said receiver interior chamber.
 34. The catheter assembly ofclaim 28 wherein said hydration element is secured to said inner surfaceof said receiver.
 35. The catheter assembly of claim 28 wherein saidhydrating element is secured to said closed distal end of said receiver.36. The catheter assembly of claim 17 wherein said sleeve is gaspermeable.
 37. The catheter assembly of claim 1 wherein said cathetersub-assembly includes an introducer tip at the proximal end of thecatheter tube.
 38. The catheter assembly of claim 1 wherein saidcatheter sub-assembly has a longitudinal axis coincident with saidcatheter tube and said aperture and said catheter tube is angularlyadjustable relative to said axis.
 39. The catheter assembly of claim 38wherein said gripping member end surface comprises a notch sized toreceive said catheter tube.
 40. The catheter assembly of claim 39wherein said notch has a key-hole shaped profile comprising a generallycircular portion and a non-circular portion.
 41. A catheter assemblycomprising: a receiver; a gripping member; said receiver and grippingmember when assembled defining an outer elongated housing; said housinghaving first and second opposed ends and a longitudinal central axisbetween said ends; and said housing having a non-circular profile aboutsaid central axis; a catheter tube carried by said gripping member. 42.The catheter assembly of claim 41 wherein said housing comprises agenerally elliptical shape about said central axis.
 43. The catheterassembly of claim 41 wherein said housing comprises top, bottomgenerally arcuate surfaces wherein said top and bottom surfaces define adiminishing taper toward said first and second ends.
 44. The catheterassembly of claim 41 wherein said housing comprises a textured surface.45. The catheter assembly of wherein said housing comprises a grippingsurface.
 46. The catheter assembly of claim 45 wherein said grippingsurface is provided on an outer surface of said gripping member.
 47. Thecatheter assembly of claim 41 wherein said housing includes an aperturein said distal end.
 48. The catheter assembly of claim 47 comprising aremovable seal over said aperture. 49.-83. (canceled)